Maturation of the Autonomic Nervous System in Prematures
Verified January 2013 by Rambam Health Care Campus
Information provided by (Responsible Party):
wamir, Rambam Health Care Campus
First received: August 23, 2011
Last updated: January 14, 2013
Last verified: January 2013
The purpose of this study is to try to evaluate the maturation of the autonomic nervous system in prematures.
||Observational Model: Case-Only
Time Perspective: Prospective
||Maturation of the Autonomic Nervous System in Prematures
Primary Outcome Measures:
- Herat rate variability (HRV) characteristics [ Time Frame: 3 years ] [ Designated as safety issue: No ]
It is well known that maturation of the autonomic nervous system can be detected by heart rate variability in children. The purpose of this study is to apply HRV characteristics in premature infants and try to evaluate if there are noticable changes in these parameters both in "healthy" and diseased premature infants longitudinally during their stay at the NICU. Outcome measures to be studied are very low frequency ( VLF), low-frequency ( LF), high frequency (HF) frequency bands in the power spectrum density (PSD) of HRV records.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
To evaluate the maturation of the autonomic nervous system in prematures by using heart rate variability analyses.
|Ages Eligible for Study:
||up to 100 Days
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423942
|Contact: Amir Weissman, MD
|Contact: Shraga Blazer, MD
|Haifa, Israel |
|Contact: Amir Weissman, MD 0502061366 ext 972 firstname.lastname@example.org |
|Principal Investigator: Amir Weissman, MD |
Rambam Health Care Campus
||Amir Weissman, MD
No publications provided
ClinicalTrials.gov processed this record on July 24, 2014
||wamir, MD, Rambam Health Care Campus
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 23, 2011
||January 14, 2013
||Israel: Ministry of Health